[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Notices]
[Pages 10767-10768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4322]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0301]


Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs 
Waiver/Reduction; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance for industry (183) entitled 
``Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs 
Waiver/Reduction.'' This guidance explains the procedures FDA expects 
to use to evaluate waiver requests under the fees exceed costs waiver 
provision of the Animal Drug User Fee Act of 2003 (ADUFA).

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document to the Communications Staff (HFV-12), Center for Veterinary 
Medicine (CVM), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit written comments on the 
guidance document to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http:///www.fda.gov/dockets/ecomments. Comments should be identified with the full title of the 
guidance document and the docket number found in the heading of this 
document. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dave Newkirk, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6967, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 17, 2006 (71 FR 47502), FDA 
published the notice of availability of the draft guidance entitled 
``Guidance for Industry: Animal Drug User Fees; Fees Exceed Costs 
Waiver and Reductions'' giving interested persons until October 31, 
2006, to submit comments. FDA received no comments.
    ADUFA (Public Law 108-130) amended the Federal Food, Drug, and 
Cosmetic Act (the act) and requires the FDA to assess and collect user 
fees for certain applications, products, establishments, and sponsors. 
It also requires the agency to grant a waiver from or a reduction of 
those fees in certain circumstances.
    This guidance explains the procedures FDA expects to use to 
evaluate waiver requests under the fees exceed costs waiver provision 
of ADUFA. These procedures may be modified in the future as FDA gains 
more experience with waiver requests.
    To qualify for waiver consideration, a written request to the 
agency for a waiver/reduction, including under the fees exceed costs 
waiver provision, must be submitted no later than 180 days after the 
fee is due (section 740(i) of the act (21 U.S.C. 379j-12(i))).

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on the topic. The document does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. Alternative approaches may be used as long 
as they satisfy the requirements of the applicable statutes and 
regulations.

[[Page 10768]]

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in Guidance for Industry 170. These 
collections of information are subject to review by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520) and have been approved under OMB Control No. 0910-
0540.

IV. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number found in the brackets in the heading of this document. A copy of 
the guidance and received comments are available for public examination 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either CVM home page (http://www.fda.gov/cvm) or the Division of 
Dockets Management Web site http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 1, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4322 Filed 3-8-07; 8:45 am]
BILLING CODE 4160-01-S